Welcome to Milestone's Commercial Investor Event. I'm Joe Oliveto, hopefully everyone in the room knows me, and I really want to start by thanking Cooley for hosting us at this great space in Hudson Yards in New York. We will be making a couple disclaimers. Number one is this presentation discusses our intended promotional launch strategy for CARDAMYST. CARDAMYST is the provisionally approved trade name for etripamil nasal spray, which has not been yet approved by the FDA. It's under review, and we have a PDUFA date of March 27th, and we'll probably have to say that a few times today. The other thing is we will be making forward-looking statements, so here's our list of disclosures, but we also point our investors to our latest 10-K for a more fulsome outline of the risk factors impacting the business. Here's today's agenda. I'll be joined by my colleague, Lorenz Muller, our Chief Commercial Officer, who will be handling the majority of the presentation today. Following Lorenz's presentation, we'll open up for a question and answer, and I'll be joined by members of the management team, Jeff Nelson, our Chief Operating Officer, Amit Hasija, our Chief Financial Officer, and Dr. David Bharucha, our Chief Medical Officer. What I always like to start with is really our mission here. We are a really patient-centric biopharmaceutical company focused on those patients with underlying needs of cardiovascular conditions, and our founding area is for PSVT and AFib. This mission really drives us. We've learned a lot from these patients. They've shared with us over the years. For PSVT in particular and for CARDAMYST, we feel that this understanding of this condition through the lens of the patient is very important to understanding the potential for CARDAMYST. We spent many years with these patients. They have very compelling stories. Lorenz will relay some of these stories. I will tell you, it's hard to do it justice trying to relay it, but we can't bring all of our patients with us, so we'll do our best job in doing that. But while this mission is very inspiring for us and allows us to come to work every day and do what we do, it's also a bit of, we believe, a meaningful competitive strength for our launch. Hopefully that'll come through as you hear the rest of the presentation from Lorenz. The last thing I would like to do is just recognize and thank all these patients. These patients have provided us counsel. These patients have provided us with their stories. They've participated in our trials to the tune of thousands of patients. They've put their trust in us, and they're putting their trust in CARDAMYST, and without them, we wouldn't be where we are today, which is really at the front door of a potential approval. 2025 is shaping up to be a potentially transformative year for this company. Obviously, if we are fortunate enough to get that approval on March 27th, it allows us to bring this drug to many patients in need and to develop ourselves as a commercial organization. We will guide and are guiding to a mid 2025 launch, assuming a March 27th approval. We realize that's a bit of a wide guidance. We will come out post-approval and narrow that guidance with more specificity with regard to when our launch will actually happen. The second area that an approval delivers for us is it opens up our AFib RVR program. An approval allows us to take that program to an sNDA or supplemental NDA pathway in which you can leverage all the safety data from the PSVT program and utilize it for your development of AFib. We're really excited for the approval from that perspective. We have engaged the FDA. We've agreed with them on what that phase III trial will look like for the AFib RVR program, and we're in the process of starting that trial now. Our goal is to have first patient enrolled in the first half. Expect this to come between approval and ideally before the end of the first half. That's our goal for the AFib RVR program. From a finance perspective, we feel well-positioned to be able to launch CARDAMYST in the PSVT indication. We've already secured a royalty financing agreement with our largest investor, RTW. This delivers $75 million in terms of upfront capital upon the approval, and we expect that amount, combined with our existing balance sheet at the time of approval, will allow runway into mid-2026. Think of it as PDUFA-plus five plus quarters of runway for the launch that you'll hear Lorenz talk about. Okay? The one other thing I will mention, it's hard to launch and do a phase III program at the same time. We will do it. However, from a finance perspective, we're going to prioritize our launch, and we're going to start that AFib phase III trial with small dollars so that we don't circumvent our launch on PSVT. Lastly, I'll mention some news that we announced last week regarding our patent estate extension to 2042. This is a result of the issuance of a notice of an issuance of a patent around our repeat dose administration. This is the administration of CARDAMYST that was used in the phase III RAPID trial and is in the NDA and is expected to be used in our AFib program. That's really nice because it does three things for us. Number one is it adds six years at the end when CARDAMYST is at its peak year sales. Number two is it brings more value to AFib RVR, which is coming later in terms of a launch. Number three, the ongoing conversations we always have with potential partners and strategics. We think this will impact those discussions and bring more value and more fruitfulness to those discussions as we go forward. Lorenz will really take you in detail through our launch. As you hear about that, one thing I wanted to mention is, our launch objectives are really informed by two fundamental beliefs or tenets that we have around this indication and around CARDAMYST. Number one is that we believe PSVT is a patient-driven market. Why is that? Because if you think about when the patient has an event, it is the patient who decides what to do. They decide whether they go to the emergency department, wait it out, try to use a drug, and they will decide whether they're going to use CARDAMYST. Really the decision is in their hands. Additionally, what we've learned in interacting with these patients and seeing the experience in our clinical trials is that patients, for a large part, who have gotten exposed to etripamil have had a good experience with etripamil, the vast majority, and they tell us they'd want to have it available for future events. Not everyone, but the vast majority. For us, it's really about having patients try etripamil. The second tenet that we have is simplicity. Really, the uniqueness of etripamil and the elegance of etripamil is in its simplicity. It is not a complicated drug mechanism. When we explain a profile of CARDAMYST to a physician, to a patient, to anyone, really, it's easy to get. They understand why a nasal spray calcium channel blocker would be used at home and avoid emergency department visits. We're going to really lean into that simplicity when you hear Lorenz talk about our launch strategy. That delivers three goals. The first goal, simple goal, for patients, make it easy to use the drug. Based on what I said before, make it easy to try the drug. What does that look like? The drug should be available at their local pharmacy or show up at their house in the mail the way the majority of their other drugs do. Not have onerous out-of-pockets, not have onerous instructions. Simple. Allow them to use the drug. For the prescribers, make it easy for them to prescribe the drug. Lean into the fact that they already are trying to do this with their patients. They're asking their patients to hold off before they go to the emergency department. That's not a good place to treat SVT, so hold off unless you absolutely have to. They just don't have good tools to do this right now. CARDAMYST is a tool that comes to them with data. There's no other available tools with data. That's a very foundational and simple message. It's a calcium channel blocker. These cardiologists know calcium channel blockers. They're comfortable with them. Just provide those simple messages to those doctors already wanting to do that work. For payers, what are payers' jobs? It's to control and manage the inappropriate use of the drug, right? They're not managing SVT right now. They're allowing ablations, they're allowing emergency department visits, et cetera. Any new drug they want to look at, they want to make sure it's used appropriately. Our job is to limit the need for payers to want to overly manage this condition or this drug. How do we do that? Simple. We provide the fact and comfort that it's prescribed by a specialty group. There's not a lot of reason for it to be abused. Provide the data that these patients are going to use this a handful of times per year, not a handful of times per month, and we're going to price it appropriately, right? Having those guardrails available for those payers is going to, in our minds, allow them to have comfort, limit their management. They will manage. Any new drug will be managed, but limit it and not make it too onerous for the prescriber to prescribe and then the patient to get. Lastly, we've really been at this for seven plus years, preparing for today, right? We knew early that we needed to learn about this market. Lorenz and some form of a team has been in place for seven plus years to learn the market, to expose etripamil to prescribers, clinicians, key opinion leaders. They know this drug. What we've done is we've sporadically placed investments over those seven years, and we're going to use that time value, almost like a compounding factor, to bring forward where we are today. We haven't been at one or two ACCs. We've been at six or seven ACCs, that type of mentality, right? We feel this strategy's been set for some time. It's a market that's not changing. We're well prepared from a strategic perspective. Really our next steps are executional, getting the approval, getting the sales force, and being able to promote. We feel we're very well prepared and that we know the market, we have the strategy, and what you hear from Lorenz is these final steps to get us to CARDAMYST on the market and uptake. Okay. With that, I'll turn it over to Lorenz to take you through the promotional plans. Thank you, Joe. I will also add my thanks to Cooley for hosting us in this lovely venue. I want to thank all of you, both here in the room and the online audience for listening to the story of Milestone, and also importantly, how we're planning on launching CARDAMYST if it gets approved. Some of you, looking around the room, I recognize from five, six, seven years now. Others I've met just literally this morning, but I really appreciate all of your interest in what I think is a really exciting opportunity to get what is going to be a great drug, if it gets approved, to patients. My mandate this morning is to really set up and educate you and engage you in how we're thinking about launching CARDAMYST in the United States. To set that up, I want to make sure and just spend a few minutes so we're all kind of grounded in the problem we're trying to solve and what we think is innovative about our solution, CARDAMYST in this case, and then a little bit of background on what the market opportunity is. Once we get through that foundational stuff, I'll spend the majority of my time talking about our actual commercial strategy and execution plans. What is PSVT? You've often heard us say this. It's paroxysmal supraventricular tachycardia. It's a mouthful, but it's essentially quite a common arrhythmia, a very symptomatic arrhythmia or abnormal heart rhythm. It is characterized by these attacks of very, very rapid rate. Not uncommon for patients to go from 60 or 70 beats per minute, normal heart rate, to 150, 180, 200, 250, literally from one beat to the next. It can last seconds or minutes or hours, and then as spontaneously as it started, it can just stop. It's a chronic condition, but it's highly symptomatic. The incidence and duration of these episodes make it very unpredictable, and that creates a lot of disruption in patients' lives and a lot of anxiety. Just to give you a little bit of some of the demographics, about half of the patients are Medicare eligible, and therefore half are commercially insured or are commercially eligible. About two-thirds of patients that have a diagnosis of PSVT are women. Most of these patients are actively managed by cardiology, and we'll come back to that again and again because it's a pivotal part or an important part of our launch strategies. That's me telling you about a disease that I don't have. I'd rather spend just a minute and a half here and introduce you to one of our patients, in this case, a woman in her 70s by the name of Donnett, who has been following our story for a number of years and who we've gotten to know. She's from Huntsville, Alabama, and she has had PSVT for quite a long time. I'd like to just give you a little sense in her words of exactly what it's like to live with PSVT. My name is Donnett Smith. I was diagnosed in my late 30s. The events leading up to my diagnosis were frustrating. I couldn't get a diagnosis. Nobody knew what was going on until I was actually in the hospital and had an episode while I was there, and they managed to catch it. They started me on medication to try to control it. It did sort of for a while, but it kept coming back with a vengeance. They tried the ablation, and it didn't work. They couldn't get the rhythm to start. I was really down and depressed about that because I just couldn't see going through those episodes constantly and never knowing when they were going to happen. I had an episode in church. I knew it was about to happen because I felt the skipped beat to start, and then it's like it catches hold, and then it's just like quivering and unprepared for it, but then it's the fear that, oh, my gosh, here we go again with this thing, and I'm going to make another trip to the ER. My husband knew I sort of slumped in the seat, so he got under one arm, the lady sitting next to me got under the other arm, and they helped me out. It's really important with the diagnosis of PSVT or any other illness for that matter, to have support from your community, whether it be advocacy group, whether a support group, whether a church group, a friend. I outsmart PSVT by knowing where I am. Whatever city I'm in, I know where the hospitals are. I look those up to start with so that I know where they are. What you can hear in Donnett's voice is that not only the disruption in her life, but the anxiety she feels when she's in an episode, not knowing when it's going to stop, and she feels like crap, frankly, when you go through one of these episodes, and also not knowing between episodes when it's going to happen next and how you're going to manage it if it does. That's one patient, one of millions, frankly, in the United States that have this disease. On the right-hand side of this slide, you can see some of the other characteristics that are, I think, important when we think about a launch strategy. It's not just patients with a diagnosis sitting at home toughing out these episodes. 500,000-1 million of these patients with a defined diagnosis of PSVT are visiting the healthcare system every year. Why? Because they seek treatment, because their episodes are burdensome enough that they want to do something about them. That's everything from a trip to the emergency department, getting admitted to a hospital, finally agreeing to an ablation, getting a script refill, seeing their cardiologist. All of that means this is an activated market waiting for us to introduce a new therapy. Let's talk a bit more about the impact of PSVT, both during and between episodes. At this point, we've engaged over 1,000 patients in market research and various other forums, and we can report that the majority experience some level of anxiety or disruption as a result of their PSVT, with most having moderate or severe symptoms during at least some of their attacks. That's important because that will make them want to seek treatment. What does that actually look like? Well, let's first talk about the physical symptoms and the emotional distress that it is part of this disease. I'll introduce you to Annette, who's one of our patients, and she happens to be a persona from our clinical trial. She's a woman in her 60s. She lives in Tampa, Florida. She was diagnosed about 20 years ago, and she has about a dozen episodes a year, so about once a month, where she wants to treat them. And she describes her worst episodes as, "My heartbeat explodes every so often." A little colloquial, but you get the idea of you can imagine that feeling of all of a sudden something's exploding in your chest and you want to stop that as soon as possible. That's just the physical symptoms. There's also social and lifestyle limitations that are associated with this disease. I'll introduce you to another patient. Actually, her picture was on one of Joe's slides earlier on. Jessica, who's in this case, a woman in her 30s, quite young, from Charlotte, North Carolina, where we have our home office. We've met her on several occasions. She stopped trail running, which she really enjoyed, for fear of having an episode far away from her car and home. Even more sadly, she declined several invitations to be involved in a wedding as a bridesmaid, maybe even as a maid of honor, for, obviously, a very close friend, for fear of having an episode during the ceremony and disrupting the focus on the bride. Imagine what that feels like, to not be able to attend your best friend's wedding because you're afraid you're going to disrupt that very special time in their life. Now imagine if she had something with her that would enable her to be able to attend that wedding because she felt like she'd be in control and could manage an episode should it happen. There's also an impact on daily functioning and productivity. I'll introduce you to Ben, who's a man, another one of our patients in his 70s. He happens to live in Bar Harbor, Maine. He takes oral drugs, that, in his own words, take hours to be effective, and leaves him lethargic for additional hours after the episode. Even though the episode may only last minutes or an hour, not only does it take a long time for them to stop with his current treatments, but he also feels very tired because of that rapid heart rate for the rest of the day, very much affecting his productivity. Then lastly, there's a pronounced fear of recurrence, knowing that it's not like you're ever going to experience your last episode unless you have a successful ablation. This idea of just the general disruption that is associated with the disease. I'll introduce you lastly to Liz, another one of our patients, who's a woman in her 50s. She lives in Ambler, Pennsylvania. When she walks her dog in her neighborhood, she always wonders, do I have my phone with me? If you're a dog lover, this will really connect with you. What if I have an episode and I'm by myself and I have a dog on a leash and I can't concentrate, what do I do with the dog? What if I let the leash go and the dog runs away? That's the kind of thought process these patients go through. She won't take a train, Liz won't, unless she has someone to go with her, because what if the episode happens on the train? How is she going to be able to deal with it? Much like Donnett needed help out of church and relied on her husband and a Good Samaritan to help. Lastly, Liz won't travel anymore. She used to love going on vacations with her husband, including going over to Europe, and now she won't even get on a plane for an hour because she doesn't know what she'd do if the episode happened in the airplane. That's the impact of this disease that we're trying to help with patients. Hopefully you get a sense of what these patients' life experience is like when they have a diagnosis of PSVT. I've alluded to it a little bit, but let me just quickly ground everyone in the current treatments that are available. On the one hand, you can try to prevent episodes through chronic oral medications, beta blockers and calcium channel blockers, primarily, prophylactically. Modestly effective, but let's face it, they don't eliminate them. Most of the patients in our studies were on a background regimen of prophylaxis, and they still had plenty of episodes. Patients can also, and I alluded to this earlier, get an ablation, which is a largely successful and relatively low-risk procedure. The issue is it's invasive. An electrophysiologist will snake catheters, typically into the groin, and either burn or freeze parts of the heart, typically very close to the AV node, to try to cut that circuit that's causing the arrhythmia. Most of the time it's successful, but if it's unsuccessful, you can end up with a pacemaker for the rest of your life. Something that most patients, 85%-90% of patients never opt for. While you're in an episode, the treatment options are more limited and less evidence-based. Physicians currently prescribe what's called pill in pocket, which is essentially taking an extra dose of your chronic oral medication in order to try to help the episode. The pharmacokinetics are completely wrong for an oral med. You want a drug ideally that has high plasma concentrations and then goes away, much like CARDAMYST does. Orals tend to slowly go up high, and then they last a long time. It's just the wrong solution for a problem in an acute episode. Patients can try vagal maneuvers, but we've even shown in our clinical program that that's effective, and we published on this, less than 10% of the time. They're toughing it out while all this is not working in many cases, or they have to go to the emergency department. We've that whole rigmarole of having to get there, having to pay for it, losing four hours, getting adenosine. I don't know if anyone in this room has ever gotten adenosine. Hopefully not, but it's a very uncomfortable experience. It's very effective. It'll stop your arrhythmia very quickly, but it essentially stops your heart in the process, and that's a very unnerving experience for a patient for the couple of seconds or minute that it lasts. Bottom line is most patients experience their attacks on top of all the treatments that they currently have and all the solutions they have available to them. Let me just briefly review the patient journey for PSVT. Diagnosis is relatively straightforward. You can see on the monitors here, starts with an ECG. Nowadays, with the Fitbits and the Apple Watches of the world, you capture a 30-second strip on a single lead and give it to a cardiologist, they will be able to tell you if that arrhythmia is PSVT or not. It's capturing the data, not interpreting the data that's the problem. Our market research suggests that the average patient takes two to three years from first symptom onset to actual diagnosis. Many of these patients will spend long hours going to the emergency department, sitting around waiting, and only at the end of that wait, by the time they finally get seen, and lo and behold, they're back in sinus rhythm, and so there was no definitive diagnosis issued. What you can see on this slide I've reviewed now, that is the four sort of approaches that currently are available in the left-hand side. That leads into what are called a vicious cycle of SVT attacks or PSVT, where patients have an episode. It could be mild, moderate, or severe. It could last hours or seconds. It could happen once a week, once a day, or once a year. We've done a lot of work to characterize this because we think it's important to understand what is our target addressable market. Not every patient will be suitable for a solution like CARDAMYST, but it turns out the majority are. In the middle of the right-hand side of this slide, you'll see a larger box that says, "Not infrequent and moderate to severe episodes." That's our sweet spot. Those are patients that have one to two handfuls of episodes a year. Half the time they are moderate, severe. They last for minutes or hours, and they really want it to stop. Many of those patients end up going to the emergency department. That's where the majority of our use and frankly, the majority of the benefit for CARDAMYST will lie. That doesn't mean, though, that physicians won't prescribe, and in fact, they will, because they've told us they will. They'll prescribe it for patients that have infrequent attacks or mild attacks because they know this is a chronic disease. Eventually, they'll have an episode that's bad enough that they need to go to the emergency department, and that'll be an insurance script. That'll be something the patient will have to confidently be able to manage it before they have to go to the emergency department. Conversely, if you have patients that have very severe episodes or very frequent episodes, maybe they have two or three or more dozen episodes a year. They're not going to use CARDAMYST on every one of those episodes. It just wouldn't be realistic or feasible. They might want to have it for the handful of episodes just before they feel like, "This is the one where I'm going to have to go to the emergency department," to try to reduce the amount of time they spend there. There's a lot of different aspects to how the patient presents, but we think there's a very solid majority of this market where we will really be a viable solution for patients that up until now, don't have anything. At the end of the day, the majority of these patients today are toughing it out at home with a handful, not a small handful, 150,000+ patients a year going to the emergency department. PSVT also costs the healthcare system a lot of money. You can see on this slide, we've done and published now, captured claims data that suggests upwards of $5 billion a year spent on treating PSVT. That's primarily trips to the emergency department, hospital admissions. You can see on the lower part of this slide, 25% of ED visits result in hospitalization, and that takes the price from roughly $2,500 for what's paid, not what's billed, to the emergency department to a $15,000+ visit for an episode of PSVT. There's diagnostic testing, there's the ablation procedures, which are not inexpensive. They're broadly covered, but they only represent the minority of the total cost of the disease. It's not like all the cost is associated with an ablation procedure. A good chunk of that is the constant engagement with the healthcare system to manage the episodes that cannot be toughed out at home. Now it gets exciting because now I want to talk to you about why we think we have such a special solution for these patients to manage that problem. Let me ground everyone quickly on just a quick refresher on the basics. Etripamil is a small molecule, not a biologic. It's a new chemical entity based on the mechanism of action of an L-type calcium channel blocker. This is technology that's been around for literally three decades, that most physicians, all physicians at this point, have prescribed, the cardiologists at least in one form or fashion. Verapamil and diltiazem, common household names, are examples of L-type calcium channel blockers. Our molecule is unique in that it has been engineered with a chemical substitution away from the active site. If you look at the actual chemical structure of etripamil, on the right-hand side, you'll see an ester group. That's novel chemistry. That's what allows the product to be degraded quickly in the bloodstream, giving it a shorter half-life or shorter rapid offset of action. It's also what gives us the new chemical entity status for etripamil or CARDAMYST. You heard Joe earlier allude to our patent life, but I want to reemphasize, we have composition of matter coverage on the molecule of etripamil through 2028, Hatch-Waxman extensions for another couple of years. Importantly, we have formulation patents that take us out through 2042 now, formulation and route of administration patents through 2042. A lot of time to get the product to patients that need it. All of that translates into the ability of the drug to empower patients to treat these attacks on their own, anytime, anywhere they need to. Let's talk a little bit about some of the key characteristics that we think make CARDAMYST a good solution for many of these patients that have attacks of PSVT. On the efficacy side, you've heard me allude to it several times now, but the fast onset delivers quick relief. We've seen that in our clinical trials from a highly symptomatic disease and these symptomatic episodes of PSVT. Safety is paramount here because patients are going to be using it on their own at home, and you don't want somebody falling over, hitting their head because they had a drop in blood pressure or some sort of conduction issue. We just don't see that in our clinical program, at least not in our pivotal trials. It's important to remember that safety is the foundational aspect of this drug that makes it deliverable in the on-demand format that we want. It's very convenient, so patients can use it literally anytime and anywhere they have an episode, assuming they're sitting down and making sure they're in a safe place. It's cost-effective. I'll show you in a minute. You saw the burden of cost of this disease. We believe that, and we've shown in our clinical trials an offset that we think will be very compelling, and we've heard from payers directly will be compelling for them. If you look at the right-hand side, those are all features or benefits of our drug. The right-hand side of this slide is what's so important, right? These are the emotional benefits to patients. This is the reason they're going to use CARDAMYST when they have an episode. It's the rapid and reliable relief that they experience from being able to manage it on their own. The empowerment they feel over a disease that heretofore too, has been completely out of their control. They're beholden to the healthcare system to manage the worst of these attacks. It provides peace of mind. It provides that reassurance, that sense of confidence that I got this disease for the first time in my life. It allows them, patients like Liz that I talked about earlier, to have the confidence to be able to go out and go on a trip. Another patient to be able to go on a trail run, you remember that was Jessica that couldn't do the trail runs, or go to that wedding that she really wants to go to. It's that returning to active living that we think is an emotional and very important benefit of CARDAMYST. I'm not going to show you a ton of data. Many of you are very familiar with our pivotal trials, but I do want to showcase the efficacy and safety of the drugs. I think that's foundational to its profile. What you see here is probably familiar to everyone. This is our Kaplan-Meier curve from our RAPID pivotal trial. What it shows, I'll give it more in a commercial speak as opposed to medical speak. This shows that at 30 minutes, more than twice as many patients convert on etripamil versus placebo. It converts more than two times as many people, and it converts them more than three times faster. Median time to conversion on etripamil here was 17 minutes, and on placebo was 53-54 minutes, more than 3x. Twice as many patients converting three times faster. That's the efficacy that we will hopefully be able to promote with etripamil. Not shown on this slide, but also very importantly, that leads to, we believe, a reduction in ED visits of almost 40%, and that is something that payers will take notice of. I mentioned safety earlier. This slide shows our primary safety results in terms of adverse events from the RAPID trial. Actually most of our AEs were route of administration mediated, so a bit of nasal discomfort. It's a slightly acidic formulation. It's a little bit of a surprise when you're sniffing it, kind of like sniffing acetic acid or vinegar. Nasal congestion, because it's a local vasodilatory agent, little bit of runny nose or rhinorrhea. We even saw a little bit of nosebleed, but they were all mild or moderate, and transient, and not requiring treatment. Broadly speaking, what was really important here is there were no serious adverse events in the RAPID trial, related to drops in blood pressure, so syncope, pre-syncope dizziness. There was also no conduction issues, no second and third degree heart blocks that could lead to those same sorts of types of side effects that we don't want. This is very important to us being able and be confident that we can allow patients to use this drug wherever and whenever they want at home. What can CARDAMYST mean for patients, prescribers, and payers? Joe introduced this concept at the beginning of the presentation. I just want to give you a little more color on this. Patients I mentioned earlier, it's all about empowerment. Patients for the first time in their lives are going to have a tool that allows them to control this disease and to have that feeling where they're not relying on the emergency department or the healthcare system, and they're going to have less fear and less anxiety and hopefully less disruption in their lives because they can manage this when and where it happens. We will enable that, our goal is to make it easy to use, and we'll talk at the back end of this presentation on how we're going to do that. Prescribers, it's an L-type calcium channel blocker. They're very familiar with it. It's trusted mechanism. We expect that could lead to more rapid adoption because they don't need to be detailed six, seven, eight, 10 times before they write their first script. It remains to be seen if this is the case, but the confidence in knowing it's a trusted mechanism, it's something they've used as a class of agents for 30 years, it should be helpful in that endeavor. We actually have evidence, unlike pill-in-the-pocket, unlike prophylaxis, which is used broadly, but it really isn't evidence-based. There's a very, very thin level of data behind that and certainly no FDA approvals behind that. Importantly, from a physician's perspective, physicians, especially cardiologists, are wired to save lives. Although PSVT is bad, it's not a mortal event. It's not like a patient's going to die of PSVT. If the patient is able to manage most of these episodes at home, the cardiologist will feel very empowered. Well, on the one hand, they'll feel like a hero because they gave the patient finally a solution. For 30 years they've been asking, and now finally they have something that works for them. They'll also personally be able to focus their attention on patients that they feel might need their more urgent attention, like heart failure and strokes and other things that cardiologists deal with. We want to make it easy to prescribe. We don't want to make this an onerous thing for the physician to have to get the product to the patient. Lastly, for payers, it's all about efficiency. It's all about being cost efficient. It's all about not being cost additive. We have what we believe is a very compelling story to be able to allow payers to accept the product on formulary without the kinds of onerous restrictions that oftentimes accompany new drug launches. Just before we go into looking at the market opportunity in a little more depth, I want to just spend a minute talking about the last stakeholder I just talked about, the payer. We all know that product launches are often successful or not based on how the product is ultimately paid for. I'll go into this in a little more detail in a few minutes. Here are a couple of critical market dynamics that I think are relevant for PSVT and for CARDAMYST, that we've heard from payers over and over again, and were therefore incorporated into our go-to-market strategies here and tactics. Starting with the unmet need, payers have consistently told us we will leave the determination of the unmet need here to cardiologists or prescribers. If there is demand, we understand there's an unmet need, there's no therapies here available. That's not something the payers are going to become involved in unless cardiologists don't see the clinical need. We know from literally thousands of interviews at this point that there is a strong clinical need in the mind of the prescriber. Joe alluded to earlier what I call rational pricing, which is if we don't price this irrationally super premium, like a rare disease or something like that. We will be able to have a strategy where we can make it accessible for the patient and not too onerous for the physician to prescribe. We anticipate having, it says minimal here, I think we'll have no branded market competition for a long time with this agent. That's important because it gives us share of voice and be able to shape the market. From a payer perspective, it's also important because it means that there isn't that rebate escalation pressure that you often see in highly competitive markets like migraine or like the novel oral anticoagulants. Lastly, and this is sort of the last piece that's important to payers, is this potential, this belief that there should be an offset. They'll have to demonstrate it in their own data, and we've demonstrated it in the clinic, but that is attractive to payers. On the margins at least, they're more likely to review it quicker because they think there may be some additional economics that they can benefit from. All right, let's briefly go back to the market opportunity and take it from the individual patients out to the full market in the United States. What you see on this slide is a summary of years of work at this point, and this has all been published. The bottom line is that there are over 2 million patients with a diagnosis of PSVT in the United States, and that they are an aggregate costing the system, as you heard me say earlier, over $5 billion a year. Very importantly, in the lower right-hand side bottom of this is what I mentioned earlier, which is 500,000 million to 1 million patients of these 2 million are engaged in the healthcare system every year. That'll be important because you're going to hear me say later that we're not focusing on patient activation as a critical launch strategy, and that means that the patients have to be going to the offices and being treated, because we're going to focus on getting the physician aware and trialing the drug in the appropriate patient. We have a lot of confidence because when we talk to almost any cardiologist that we've interviewed, they say, "Lorenz, I see these patients weekly. I don't see them daily like I see AFib patients, but I see them every week in my practice." As long as that is true, that'll be an opportunity for them to write, and you'll see in a minute how much they're going to write, based on their own stated adoption for those patients. The rest of the numbers on this slide represent the critical elements of cost, the ablations, the emergency department visits, the inpatient admissions. The numbers I showed you earlier are on the lower end of these ranges, but we continue to publish and research, and every time we look at these data, whether it's ICD-9 or ICD-10 codes, which we're now publishing on, the numbers just keep getting bigger. I don't want to be irrationally exuberant, but I'm telling you, the numbers that we're giving you are on the lower end of the likely range for what we will actually see for cost and for the engagement with the healthcare system. The other critical variable, if you're trying to model how we might launch the drug and how it might do, is because it's a PRN drug, it's going to be used as needed as patients have attacks. How many times a year are they going to use it? With a chronic oral med, you give them a script and they're taking one tablet a day for the rest of their lives kind of thing, right? That's easy to model. In this case, it's important to know how often will a patient have an episode and which of those episodes will they treat. On the left-hand side of this panel, you'll see our estimate of roughly three to five times per year that patients within our target addressable market will use CARDAMYST to treat an episode. Our evidence for that is both randomized clinical trials, where we've extrapolated the annual projected use, our open label safety studies, where they had access to multiple doses a year, as well as an observational study we did where we literally followed 250 patients for an entire year and asked them to log in every time they had an episode and tell us about it, and our market research. The good news is, as a commercial person, I love it when data sets converge like this. The answer essentially is the same across all these, which is somewhere in that range of three to five is a sweet spot for how patients will use it. That doesn't mean in our launch year, though, for those of you that are modeling our launch, that doesn't mean you can take credit for three to five episodes treated in our launch year. Why? Because a patient's going to get a script, and then they might not have an episode for two or three months, and if they get that script in October of our launch year, they're probably not going to actually use the drug until December, and so you're not going to have two or three refills on that drug in that year. But as we have more and more patients refilling prescriptions and not new patient starts, that number's going to drift up. We estimate on the right-hand panel here, one to two uses a year in 2026, and then it'll start to steady state out in 2027 and beyond to that three to five target. It's very important to model this correctly because it's a big driver of our performance. I also want to remind you that, and I said it earlier, but it bears repeating, the majority of the patients in this market, of those 2 million patients, are being managed by cardiology. That's important from a launch strategy standpoint of who we call on, where we create demand. It's also important as people do calls and as investors thinking about doc calls, make sure, go ahead and talk to your electrophysiologist. That's fine. They are the subject matter experts here. Make sure you call a couple of clinical cardiologists as well, because their opinions matter because they will be seeing the majority of the patients that are appropriate for CARDAMYST. Later on, we won't talk about it much today, but there is an opportunity with primary care as well. We will target a few of those in our launch, but really that's something that we can grow into as we get two or three years beyond the launch. Let's come back to the patient journey that I showed you earlier. What I've done here is the exact same chart, except I've superimposed now where the use cases that physicians tell us from a profile we've showed them they would use the drug. You can see, and this is also music to my ears as a commercial person, they're pretty much telling me, no matter how they're currently managed, I see a use case for CARDAMYST. For patients that are on prophylaxis, chronic oral meds every day, they could see adding that on top of prophylaxis if they can tolerate those drugs, or they can see if they're not tolerating the beta blockers and calcium channel blockers that do have side effects, they can switch them and just give them CARDAMYST, and they may have slightly more episodes every year, but they can manage them with CARDAMYST as they have. For patients that are taking off-label pill-in-the-pocket, most physicians admit this is a better solution. It's evidence-based, and it's clearly faster and just as safe. We expect them to be able to switch a patient that's on pill-in-the-pocket, about 30% of the market, to CARDAMYST. If they want to leave it up to the patient, we're fine with a patient having an extra pill around and CARDAMYST. They can decide in that moment, am I going to take the pill-in-the-pocket, which if I have time, I can wait for it to work, or do I want to take CARDAMYST because I had to pay a $50 copay for that, right? We'll leave it up to the patient, but there's plenty of episodes to treat. Even the patients that are getting no treatment, either because they don't tolerate the meds that they're given or they just don't have sufficient disease burden, this is our insurance policy patient, in some cases, where they'll get a script, no harm in doing that, and then before they have to go to the emergency department, if they have a bad episode, they'll use it. In a minute, I'm going to talk a little bit more about the electrophysiologist, but there are two use cases there as well, whether it's a bridge to an ablation when the patient is scheduled for the ablation, but in five weeks, they're going to have it to make sure they can cover any episodes they have there. For the 20% or 30% of patients that the electrophysiologist, despite their best efforts, can't convince those patients to have the ablation. That's another place where they can and they would use, and I'll show you some data around that in a minute. Nice broad set of use cases, and we'll be very selective when we go out with the salesforce to make sure we're clearly painting the picture of where the product should be used, CARDAMYST, to make sure that it's clear for physicians. This is now the translation of that theoretical, where it's going to be used, or the stated where it's going to be used, to actually quantifying it. This was from a large quantitative study. Folks in the room have seen this before. Left-hand panel shows the current treatment, where you see about a third receiving pill-in-the-pocket script, about a third getting a prophylaxis script, about a fifth getting no treatment, and then that 10%-15% getting an ablation. That's how their physicians report, cardiologists in this case, how they're currently managing. When they see a profile of CARDAMYST that we showed them in research that is virtually identical to what we expect our labeling to be based on the RAPID trial, we see that two-thirds of pill-in-the-pocket scripts, no surprise, they're going to get a CARDAMYST script, either added or replacing that script. About half the time when they're on a chronic med, they will also get a CARDAMYST script. About half the time when they're on no treatment, they're going to get a CARDAMYST script. It'll be up to the patient then to fulfill that at the pharmacy and take it when they need to. In aggregate, almost 50% stated adoption. I mentioned earlier, talking about the electrophysiologist. I wanted to give you a little bit of data because the EP could be viewed here, EP meaning the electrophysiologist, as antagonistic. You're taking business away from my ablations. I do ablations. That's what I do. This is potentially a replacement. That is not how EPs are thinking about this drug. We are not getting in the way of ablations. When we launch CARDAMYST, we will embrace ablations. For a patient that needs an ablation and wants the ablation, we will encourage them to go get it, because there's plenty of patients out there for us to help and not fight for that one. That's important because the EP sees a use case where CARDAMYST would help their procedure, whether it's a bridge to that ablation, or whether it's a replacement for it for that period of time where they can't convince the patient. Either way, they're appearing to be helpful to the patient, and if that patient eventually decides to get that ablation, they will be able to get it from that electrophysiologist. These data on this slide here show that when we ask electrophysiologists, a decent sized cohort, how often would you prescribe CARDAMYST in a patient that you were going to be ablating? A third of the time, they said that patient would get a script. For the patients that they can't convince to get an ablation, remember, in aggregate, they're only seeing 10%-15% of the patients, and about 20% of the time, they can't convince those patients to have the ablation. They're saying about a quarter of those, I would also offer CARDAMYST. It's not a lot of volume necessarily, although it could be a decent amount in a launch year. It's very important that our influencers, that our people that are respected in the community, are influential on guidelines, and on P&Ts, have experience with our drug. This is the use case, and we will advocate for this with our sales force to make sure they are competent and comfortable advocating for the use and seeing a role for it. Before we move on to the last part of the presentation on our planned launch strategy and execution, let me summarize from my view why CARDAMYST offers such a compelling commercial opportunity. If you ask me what I think is an ideal market into which to launch a new drug, I would describe to you a market that first and foremost has no competition, in this case, no branded competition. That should be self-evident why that would be desirable to a commercial person. I would describe to you a market where the primary prescribers are very familiar with the new drug's mechanism of action and impressed with the clinical evidence. Coming to market with actual clinical evidence, Kaplan-Meier curves, things that resonate with the target market, in this case, cardiologists. Lastly, I described to you a market where the dynamics are such that there are tailwinds in terms of early demand generation, which I'll get to in a minute, and where payers are unlikely to want to actively manage the drug based on the pricing strategy and how we engage them, as well as the cost offsets. That, folks, is, I think, what we have here with the launch of CARDAMYST. All right, this is what you've all come here for. Thank you for allowing me to preamble and maybe set up the table a little bit. Now we get to dig into the main meal here. How are we going to launch CARDAMYST? The hows and whys and whats of how we launch. First and foremost, a launch entails a launch team. I'm very proud to say we have assembled what I think is a top-notch commercial team and a medical affairs team. You see them on the slide here. Many of these folks have been with us for several years. A few, like Jeff Moore in sales, just joined us three or four months ago. Across them, averaging 25-30 years of experience launching drugs. Specifically, this team has launched several billion-dollar drugs that you might be familiar with, from Plavix to Ranexa to Jardiance to Pradaxa. All cardiovascular drugs, and then at least six or seven other non-cardiovascular drugs, all of which achieve billion dollars in sales. This team knows how to launch a drug, how to do it in large companies, and how to do it in small emerging life science companies. You can see the names across the bottom. They've been around long enough with us to be working as a highly functioning team. I am as confident as I've ever been in a launch with this group at the helm. What's our strategy for how we're going to engage the market? Are we going to do shock and awe and throw hundreds of reps at this right out of the gate like some companies do or used to do anyway? No. We believe in this model of a staged launch, and there's a number of white papers out now, and you see more and more even Big Pharma doing more of a staged launch, chasing certain access goals. Let's start with the pre-launch period, which we've been in now for a while, right? We've been actively engaging the market. Joe alluded to this earlier. KOL engagement with various medical teams, field teams, engaging with electrophysiologists, cardiologists, generating awareness, and getting them engaged in various ways, including our clinical work. We also, for more than a year now, have had a national account team out there engaging with target payers, commercial and Medicare, and IDNs, frankly. Some cases we went to them, some cases they've come to us to ask about this new launch. Anyway, we want to know where we're going to stand and what we need to do to inform all of our strategies, including pricing. We've now done that. If we get our approval here on March 27th, we will now go to market with a sales force. We will target in the launch year, what we call high-value prescribers. There's about 10,000-12,000 of them here. They're primarily cardiologists, but there's some electrophysiologists and a little bit of primary care in there as well. They're the highest volume practices. We've done claims analyses to know exactly where they are, how many patients with PSVT they treated in the last three years, how many drugs they prescribed that are cardiology drugs. We can then target and put these valuable resources, these reps in a launch on the most attractive targets. We're also going to focus with payers on commercial access, not because there isn't business with the government or with IDNs or other areas, but that's an area where we know half the patients are commercially insured, and we believe from engaging payers that we will be able to get more quick access established in the commercial side than something like Medicare that just takes a little longer with all the cycles. That's the strategy for the launch year in terms of a go-to-market. Then as we get into 2026 and 2027, with success, we'll be able to expand the sales force, target more doctors, initially, maybe up to 22,000 doctors, and eventually upwards of 30,000. Really saturate cardiology and prescribers that look like cardiologists. We will, at that point, establish broad commercial access. We'll move into getting national formulary decisions with Medicare as well in that 2026, 2027 timeframe, and IDNs as well, both proactively and coming to us. Let's face it, integrated delivery networks should understand a value prop where you have a medical cost offset because they would value that more than, say, a PBM, where they're really just thinking about the additive drug cost. A three-phase stage launch going into the approval here. Let's now talk about why we can expect to be able to deliver a broad quality of payer coverage. I'm going to spend a fair bit of time on payers here because it's a very important thing for everyone to understand. What we've learned from our market research thus far, and it's been with over 100 regional and national payers, both commercial and Medicare, is that first and foremost, they don't currently actively manage PSVT. There's been no innovation here on the drug side for almost 30 years. Most things are generic, and so they just don't manage it. They tell us, "By the way, we don't want to manage it, and it costs us money to actively manage it. So if you price it rationally," and we'll go into that in a minute, "then we will have no real need to limit its use long term. We will work with you during a launch year to make sure that you have a decent chance at demonstrating demand." Lastly, I mentioned this several times now. They're genuinely intrigued from Humana to Aetna to CVS, genuinely intrigued by this potential for cost offset. That is something that is front and center both in our payer presentations as well as in our budget impact model that we've shared with them to date. Given this context, here's how we believe we can deliver broad quality payer coverage with CARDAMYST. First, we plan to price CARDAMYST so that the net price to Medicare is below specialty tier. What does that mean? Medicare each year sets a threshold on a monthly basis of a dollar amount that if you price it over that, it can just put the drug when it's approved into specialty tier, which means not just high co-pays, but typically co-insurance. Patients who, in our case, are going to be spending hundreds of dollars on a co-pay or co-insurance, which is unaffordable for most Medicare. We don't want them to do that. If we set a price that allows us to rebate Medicare below that specialty tier threshold, which right now is $950 a month, we'll call it $1,000. We price it over that threshold. We rebate Medicare down to that. We cover our other costs, and that gets us down to a net sales price to us of somewhere between $500 and $1,000 per prescription. WAC above $1,000, rebate down to get Medicare to not put it into co-insurance or specialty tier, so a non-preferred, preferred brand tier, and then cover our other distribution and other costs. That allows us to very confidently take in as a net sales, basically dollarize demand at a net sales price of somewhere between $500 and $1,000. We do all this because remember our two goals at the beginning. We don't want CARDAMYST to be a hassle, to be onerous for physicians to prescribe. We don't want a lot of prior auths and all those hurdles that the payers can put in front of doctors where they don't want them to write a lot of a drug. We want it to be accessible and affordable for patients. We want to go with a retail distribution strategy. It'll be available at the CVS and the Walmart. We'll probably have some sort of mail order overlay on that just to make it easy to get, not specialty distribution. It doesn't merit it. We'll price it at a point where their co-pays are affordable, initially commercial, and over time, also Medicare. Here's a little more detail on that. On the left-hand side, you can see our commercial coverage goals, on the right-hand side, Medicare. I'll focus most of my time today on the commercial side because that's the goal here. We want to get the commercial side to where we think we can have quicker decisions made by initially the three big PBMs, but eventually the regional and national carriers as well. It's all about providing them, demonstrating the value, and then showing them that they don't need to put onerous utilization management in place. What we think, we're going to have some utilization management, all drugs do. At a minimum, they're going to have what's called a prior auth to label, which just means we're going to pay for a drug as long as it's being given to a patient with the disease the drug was actually intended to, in this case, PSVT. As long as the physician attests that this script is for a patient that, in my professional judgment, has PSVT, that'll be good enough in terms of what we call a prior auth to label. We expect some quantity limits. Payers, in fairness, don't know. I tell them three to five times a year, there are patients out there that could probably use this every day. Payers are going to be a little concerned. They've told us this. Until we know, we're going to be concerned of over-utilization. Not off-label use, not the wrong patient, but an on-label patient using it too often. We'll give you a quantity limit. We might give you 12 a year or 10 a year or something like that. That's fine with us because we think the typical patient will use it three to five times a year. Frankly, if they are using it 20, 30, and 40 times, they probably should be thinking about getting ablation. Lastly, it's possible that we would get a specialty prescribing. Most of the prescribers here are cardiologists. Most of the people we're targeting are cardiologists. If a payer said, "Hey, I really would like to have this in the hands of the specialist for a launch year, and then maybe over time go to primary care," we would also be okay with that. The focus, as I say, in 2025, this is the right-hand panel, is commercial. That doesn't mean we won't selectively contract with Medicare should they come to the table, or IDNs or other government entities, but it won't be the primary strategy. That will shift to in 2026 and 2027, which is when we do expect to be able to get broad national coverage decisions, everything from Medicare payers to VA to DoD, Indian Health, et cetera. IDNs are always in the mix because of the value proposition we just talked about. Here's how I define the critical milestones for the launch of CARDAMYST. It obviously all starts with the potential FDA approval on March 27th. That's when the machinery gets rolling. We've been building toward this with infrastructure and everything else, but that's where you really start to hire your sales reps, where you start to really go to market. We'll focus primarily on getting product in channel. You heard me say big three wholesaler, plus some regional wholesaler distribution to the pharmacies. We want to get the reps hired, trained, deployed with FDA-approved tools so they can deliver a competent and clear message to their targets, and we expect to have that done by middle of 2025. Along the way, we're building infrastructure to make sure that we have tools for physicians to tap into if there are prior auths that are menial paperwork to facilitate that process. We're going to have systems in place for a patient that gets a script to have the support they need to make sure they're taking the drug correctly, they understand how to use it, they'll be reminded about the refills and all those kinds of things that you do with patient CRM. We have a field team, obviously, continuing to build relationships with target cardiologists and electrophysiologists to continue to build that advocacy. Where are we on all this? I mentioned earlier that Jeff Moore, our VP of Sales, has been hired back in December. We have subsequently hired regional sales directors, two of them, East and West. We've also just recently hired our eight first line or division district sales managers. We'll have eight districts reporting into two regions, reporting into a sales VP. We're right now on the cusp of literally in the next two or three weeks, going out and recruiting a whole bunch of sales reps. We will have those ready so that when we get approved or if we get approved, we'll be able to make them offers. We're not taking the risk of hiring them ahead of approval, but we will be in a position to very quickly get them hired, into training, and deployed by the middle of the year. We've already signed our critical distribution contracts with the big three wholesalers. We, as I mentioned, have account managers out there for over a year right now. We have what we think are fit for purpose type reimbursement support programs, including things like prior auth prosecution, but also for the patients, co-pay mitigation, which will be important in a year where we don't have necessarily coverage on day one. These, I think, are the couple of critical things to think about in a launch year that we have to get right. Physicians have to write scripts and those scripts have to be filled. Pretty straightforward, right? The good news here is that we think our initial sales force will cover a good chunk of the potential in the market, meaning the patients we can see in claims data, we can deploy reps against about half or a little bit more than that of those people that are actively engaged in the system. We have confidence that these patients are in the system weekly, so we've just got to get the doctor to recognize that patient, see them in the office, and have knowledge of etripamil. The bar to prescribing, as I mentioned earlier, is going to be low. Doctors tell us this because they're very familiar with the drug and they clearly see the need. Once the patient has the script, of course, it's really important that they can get it easily. We talked about retail distribution. It's important that they have tools to be able to either make sure the prior auth is not an issue for the doc, but also for the patient to make sure they understand how to use it and can do it safely and effectively. Again, we have no branded competition that we're aware of, so there's nobody counter-detailing us here. That's very, very important as well. Of course, the healthcare cost offsets continue. I've been focusing mostly on talking about in the context of a payer, but cardiologists are also very interested in not sending their patients to the emergency department. That's another part of the sales pitch, if you will, that'll be important and will resonate with them. We're going to have all sorts of things we measure into this launch in terms of how it's performing. I want to highlight for you a couple of strategic objectives and then some of the key metrics that we'll be talking about more and more as we get into this launch. First and foremost, driving physician or prescriber awareness and adoption. That's our critical strategy. We will be able to measure that because we will be retail distribution. We'll be getting weekly NBRXs, new to patient starts. We'll be getting week-over-week script growth that you can calculate. We'll be reporting on that. You all will get that data as well. Those will be our key metrics to really determine have we got the launch dialed in correctly. To enable that and make that profitable over time, obviously, we want to also establish and maintain broad access. There, we're going to have clear metrics on the number of initially commercial and over time, other payers, how many lives are covered, and how many of those lives are contracted with what we would call acceptable coverage, which is the utilization management we can live with, and the product is in a tier where the co-pays are affordable. These are the kind of metrics that we're looking at and that we'll be talking about over the weeks and months going forward. Here's where we are in the middle here. Obviously, last year was all about building the foundation, filing the NDA. Thanks to the regulatory and clinical teams here for having us very close here to a PDUFA date. We've spent a lot of time publishing. Those of you who've been to our websites know we have most of our clinical and a lot of our health economic data published for your review. It's also important because it goes into the dossier that the payers see, and they like that kind of evidence. I've been engaged in KOLs for the better part of my tenure here, six, seven years. We've been working on publishing real-world evidence, which is very important as well. As I mentioned earlier, we hired the majority of our commercial and medical affairs leadership team for this launch at the end of last year, although several have been with us for a number of years now. This year it's all about getting approved, and if we get approved into the channel, implementing the stage launch, getting all those different support services in place and focusing on commercial coverage. Those will be our true north for 2025. Then we'll have the opportunity in 2026 to expand the number of sales reps to initiate patient activation. This is something I mentioned earlier. We're not focusing in launch year on getting patients to the doctor, but let's face it, there's patients out there that would benefit from that kind of messaging. We'll start that with rigor in 2026 with both initially direct to patient marketing tactics, and eventually I could even see this market benefiting from DTC, but that's a ways down the road. We will engage in some peer-to-peer work, but in 2025, the majority of it will be in 2026, really ramping it up. As I mentioned earlier, we'll expand access, contracted access from commercial to government payers and some of the target IDNs. Here are my takeaways for what I think is what makes this such a valuable investment thesis here for Milestone and for CARDAMYST. Hopefully, I've been able to convince you that Milestone represents an attractive investment, both in the near term based on the imminent launch, should we get approved from the FDA for CARDAMYST and PSVT. Also because of the midterm clinical development, you heard about AFib from Joe, and commercial catalysts as we sort of expand and eventually hopefully launch a second indication. Here are the central tenets for the investment thesis on this slide. PSVT is a clear unmet need without good treatment options, affecting millions of patients, many of whom seek treatment every year in the healthcare system. That's the opportunity we're going after. CARDAMYST is a compelling and efficacious first of its kind solution for treating episodes of PSVT with a favorable safety profile that's so important for its use on demand at home, which delivers fast symptom relief anywhere and anytime a patient wants to use it. CARDAMYST is appealing to payers because of its potential for cost offsets and based on reductions in ED visits and hospitalizations. The market dynamics are such that we believe Milestone can launch CARDAMYST successfully by generating early demand and then expanding into both broader markets and hopefully a new indication. With that, I'll stop. I really thank you, both here in the room and online, for your attention. Turn it back over to Joe, and we'll have some Q&A to expand further on what we've said today. Thank you. Great. Thanks, Lorenz. I'll ask the rest of the management team to come up front and take questions, I guess, in the room first, and then if there's any online. Anyone have a mic for Ted? Okay, right behind you, Ted. Hey, Joe. How are you? Good morning, everybody. [audio distortion] I think you can go, Ted. They can help themselves. Great. Thanks so much for hosting us today, and appreciate the whole team's effort here over the last several years. Clinical, regulatory, Lorenz and his whole team's work on the commercial side. Really appreciate it. I guess I had two questions. I didn't notice a specific rep number. Are you sharing that? Maybe you can give us a sense, ballpark. It was helpful to know that there's eight regions that you're looking at. I wanted to come back to this concept of DTC advertising, because you said that the patient will really be driving this. So how do you reach those patients and educate them? Obviously, it's sort of hand in glove patients and physicians, but how do you get to the patient and really let them know about CARDAMYST upon launch? Thank you. Yeah. Thanks, Ted. Lorenz, I think this is right down your sweet spot. I think it was just by omission that we missed the reps. Why don't you take that first and then tell him about the stage engagement with the patient? Yeah, love to. Thanks for the question. Ted, so you've heard me historically say 50-100 reps is sort of the beginning of the stage launch. We have eight districts. I'll correct you, it's eight districts in two regions, and we expect to populate those eight districts with around 60 reps, is what we're targeting for the initial deployment. Might be ± 5 either side, depending upon exactly when we hire them and everything else. That's the number we feel that will get us to that core group, targeting the majority of the commercial claims that we can see in a given year. Hopefully that's clear, two, eight, and then 60. In terms of the way to activate patients, 20 years ago, it was a blunt tool called DTC. You just ran TV ads, and you ran them over and over and over, and you spent hundreds of millions of dollars doing it. Some of our competitors or pharmaceutical peers are still doing that. It works. The reason people do it is it works, but it's not the only way to do it, and it's very expensive. How we think about this is, I referred to in the presentation what I call direct-to-patient tactics, which is direct-to-patient marketing. This is everything that internet, social media, phones enable in terms of geotargeting and all the things you can do to get messages to patients in a much more surgical manner, where you're not just carpet bombing, which is essentially what you do with TV advertising. We're doing some, but very little of that in our launch year for the reasons I outlined, because those patients that we're targeting are already going to the doctor in the launch year. We see the advantage over time to building that. We will start in 2026 with a reasonable investment in direct-to-patient tactics, everything from streaming TV to point-of-care advertising in the doctor's offices to social media, that kind of stuff. Then eventually, I could imagine us two or three years down the road doing some pilots and looking at region or test cases of actual TV ads to see if that would work b ecause there's a real market out there with real patients that are not seeing their docs. The good news is at least half of them are seeing their docs, and so we don't need to do this and spend the kind of money, frankly, that direct-to-patient or direct-to-consumer advertising costs in our launch year. Yeah. Ted, I'll just add to that. One other philosophy we have going into the launch is to keep a little bit of our powder dry so that we could see and measure a lot in 2025 and early 2026 and see what's working best. Right? By having some dry powder, then you could figure out which one. We know that we hope that 80% of it's going right, but dial up the ones that are going really well in the promotional efforts and dial down those ones where we're spending money where we're not seeing the bang for the buck. Any other questions in the room? We got Brendan here. Oh, okay. Oh, sorry, Les. Thank you. Les Sulewski from Truist. Thank you for the presentation today. It's my first time hearing it, so very impressed with the progress you guys made. Just a little bit on the PSVT patient progression, can you tell me about the severity levels? Do they go up with time? Is it a lifelong disease? Eventually, does that patient get to that 10-12 per year attack threshold, and then they go for ablation? The second part, didn't really hear much about manufacturing or your CMO, which I'm assuming you have a partnership with someone. Just talk a little bit about that, and then a follow-up to that one will be, what is the shelf life of CARDAMYST? Thank you. All great questions. I'll start by saying, hand it over to Lorenz for the progression of the patient. It is very variable. When you meet one patient, you do meet one patient and hear their story. Lorenz, maybe you can tell him about our research and what we've heard from these patients in terms of progression, and then I'll jump in. I'll ask David to opine as well from the medical side. What we see from all the engagement we've had, primarily in our observational studies and market research, PSVT is not progressive in the way other heart failure or AFib, where AFib begets AFib and all that stuff you've heard. Patients can have their first episode of SVT, and it can be really bad, and then it can be very frequent, or it can be infrequent, it can be really long or really short. It can change over time. The inter-patient and intra-patient variability is huge. In that sense, it's not going to feel to the patient like it's progressive disease because a lot of it is based on not just having a short circuit in your heart, but also how stressed you are, what's going on in your life. Patients have told us, "I used to have..." This is literally from our outcome study. We had a patient say, when we asked them, "How many episodes did you have last year?" They said, "six." Then we put them in our observational study, and they had 20 or 30. We thought it was somebody making data up. We actually contacted them appropriately and said, "Hey, what was going on? That doesn't seem to be consistent with your baseline." He said, "Oh, well, I got divorced. I'm battling custody for my kids. I had a really stressful year, and I noticed that my SVT got a lot more frequent." They're not progressive in the way you're thinking about it with disease progression. It is more based on how that particular patient is living and what's going on with them. David, anything from a medical side? Yeah, sure. Just to introduce myself, my name is David Bharucha. I'm the Chief Medical Officer here at Milestone. I'm also a cardiologist, specifically a cardiac electrophysiologist. For the last several decades, these are the patients I've been dealing with. We also have a ton of familiarity with these types of patients, as Lorenz already described, just through our clinical programs and through some of our already existing patient outreach. The key things to think about with regard to these patients and their episodes, to amplify what Lorenz has already said, is patients just don't suffer during an episode if they have to go to the ER or whatever. They really suffer and their lives are disrupted between episodes. And you can imagine, one frequent question that patients would ask me when they come in after one or two episodes of PSVT is, "When's the next one going to occur?" I really never had a clear answer for them. In fact, anyone who tries to give them a clear answer, the data out there are just very variable. It really reinforces the need for someone to be carrying with them just a backup device in case they go into it a month later, six months later. They can also have the latitude to, let's say, go on vacation, go kayaking in Alaska or whatever, without thought of, "Oh, gee, I'm well away from an emergency department." That's one major observation about patients' experiences of episodes or patients' experiences of the uncertainty between episodes. The other thing to reinforce, and just to tag it on to what Lorenz already said, patients during an episode, these are not minor palpitations. "Oh, did my heart skip a beat? I'm not quite sure." No, this is like you're running a marathon. For multiple different reasons, this is very disturbing to patients. These are not nuisance symptoms. Lorenz, those are the two areas I'd privilege on. Thank you. Okay. Last, you asked about CDMOs. I'll speak a little bit more generally about our supply chain, if you will. It's primarily three main components. It's the API manufacturers. It gets then transferred to what we call drug product or final finished form manufacturers, and then packaging and then distribution. It is a drug-device combo, there is a device component to it as well. We have, in our NDA, a single source API supplier. It gets then transferred to two different drug product suppliers in our NDA. One is a primary, one is a bit of a secondary or backup supplier, we'll have one available at launch, is our expectations, with another one in the wings should we have any problems. The reason for that, and we are clear with this as risk factors in our 10-K, is if there is a bit of a risk on the supply chain, we see it in the finished form fill. It's a specialized vial that goes into this device, so it's not as prevalent as you might imagine. For example, regular vial filling. This is your specialized vial. They don't look really any different, but it takes some special machinery. That's why we invested the time and money to actually have two drug product suppliers on that side. There's a drug device combo. The device components come from the one supplier we are clear with is Aptar. They're the 800-pound gorilla in the device world. They have many devices, nasal spray devices out on the market, and we get those components, and we assemble it where we fill finish, if you will. You asked about, I guess it was shelf life. Right. We're anticipating a shelf life of at least 18 months at approval. We're hoping it could be longer. We think it's very valuable for those patients that don't know exactly how many episodes they're going to have, to have something that's not going to expire too quickly. We have a thought that it should be at least a minimum of 18 months. Room temperature. Oh, room temperature. Yeah. No special handling. We have Brendan here. Yeah. Thanks very much for hosting us. Of course. Brendan Foe from Rodman & Renshaw. Maybe just any color on patient assistance programs at launch. You highlighted the one script in 2025 and showed that progression. Is that paid scripts there? Maybe just, given that this is a patient-driven market that you called out, should we think of some patients maybe being high users, sort of beyond maybe that sort of 12-15? Could you consider putting in any patient assistance programs for those who may sort of reach those quantity limits that insurers are thinking about? Right. We have ongoing, you can call them compassionate use programs now or expanded access programs. We will be transitioning to a small assistance program, really for learning. I think you should be proud to explain. Yeah. It's not just about patient assistance as you know. It's the total offerings around when a patient has a question, there's a phone number to call, and then you have a whole bunch of services tied to that. Some of it depends on the patient question. To answer your question directly, we will have a patient assistance program. It'll be in that overall phone tree. People will have to qualify for it and all the loops you have to go through, but for patients that do qualify, drug will be made available to them. But on top of that's the minority, frankly. Typically, 2%-6%, I believe, is what you typically see in terms of patient assistance utilization of drugs. For us, it's more important for the majority of patients, whether they're commercially or otherwise insured, so they understand if they run into hassles about getting the drug, how do they overcome them? How can we help them? Once they have the script, how can we support that it's used correctly, that they know they need to get a refill when they use it, et cetera. It's a whole constellation, if you will, of patient support services, of which PAP is only a part. Yeah. Brendan, the second part of your question was for the high users, if you can explain that a little. Just in patient-driven, right? If a patient has good experience with this. Do you think that this is me talking. Okay. You would expect that perhaps they want to maybe try every incident, try the 12-15. Maybe in year three, four, they may start to reach those usage limits. Do you expect, I guess twofold, one, to either put any support program for those high users who may go above s ure limits. Right. Or secondly, would we think about perhaps if you show health economic data that those limits, RCA limits get reviewed in year two, three, four? Yeah, I'll start, but again, Ashley, I think because you're really more engaged with the payers. This is a discussion we're constantly having with the payers, right? They're worried about that too many of those patients, right? We know that there are patients that are having this weekly, if not daily. We hear about those patients. We don't think they're the greatest candidates for etripamil, but if it starts to go that path, we think we'll run into limits that they'll have brakes on it, right? Then they'll come to us, right? I think for us, it's about educating that patient as to what to use it for. Lorenz, it's actually very true. We will guide that patient to an ablation. We don't think we should be paying. They should be using that drug and paying for it. We don't think it's cost effective if they're actually going to use it that much at the prices that we're thinking about. I think that fundamentally is how we think about it, but I don't know if there's anything more specifically with the high-use patients. No, I think it'll also be somewhat self-limiting. To answer your question directly, in a launch year, we expect quantity limits. We think they're appropriate. We don't want them to be one or two. We want them to be six to 12 kind of thing, so that our typical patient will have access and have a good experience treating most of their episodes. Our big payers will collect data, real-world evidence in their own practices. In a year or two into this, they're going to see whether we were right and the average utilization is three to five, or whether it's all nine, 10, 12, and there's still an issue. We are very confident it will be the former. Then they're likely to lift those quantity limits. The reason I say it'll be sort of self-managing is because for a patient to use it every day, as a branded drug, they're going to be shelling out $30-$50 copay for every one of those episodes. Most patients won't want to spend that much money on it. We won't have a program to get them beyond the 12 script, everything else free. That's not really how this works. We will then educate them and work with them to say, "Look, if you're having this frequent a type of episode," the rep would work with the doctor. Doctor brings it to the rep's attention to say, "Look, you really got to work on trying to find a better solution for Mrs. Jones than using this every week. Yeah. Oh, I'm sorry. Hold on, Luis. Yeah. Okay, Athena. Sorry. Hi, this is Cynthia for Dennis Ding at Jefferies. Thank you for the very in-depth presentation. I wanted to ask on launch timing, you mentioned that would be gated. You mentioned you would come out with more specific timing post the approval. Just wondering what's gating that. Is it just sales rep hiring? Are you going to wait for some reimbursement to come online as well? Then just on commercial reimbursement for 2025, how do you see that cadence coming out throughout the year? Thank you. Yeah. I was really referring more to the nuts and bolts and the logistics of getting drug into the channel, getting reps hired, getting materials approved, promotional materials, and then getting reps on the street. We want to guide to a mid-2025 launch, but really give specificity so that when we actually start getting real scripts, you'll see is this relative to a specific launch time. Okay? We just want a little bit of breadth, given this our first time going through a launch and just having a little bit more leeway for when we'll actually have reps on the street with promotional materials and drug in the channel ready to go. That was really the reason for that. We're not going to wait for coverage to start to launch, if you will. With regard to coverage, though, we will report out on coverage. We're not going to provide guidance per se on what good coverage looks like in advance, but we will be tracking it because that's going to be a big important factor for, again, these dials up and down that we want to do, to be able to drive scripts in the second half of 2025 into the first half of 2026. Okay. Just to follow up on the copay, do you see that differing between Medicare and commercial and what the average would look like? Yeah. I don't think we have averages, but you can explain a little bit the tiering system. Yeah. You've seen one payer, right? In general, out-of-pockets on the commercial side are lower than on Medicare. This is all within the bounds of copays. What we're trying to avoid, and what I was describing earlier on is, we want to avoid co-insurance. Typically 15%-20%-25% of the WAC, right? Now you're talking multiple hundreds of dollars. That's not affordable for Medicare. We want to contract to keep out of specialty tier. Tier 2, Tier 3, so typically branded or preferred or not, or branded not preferred tier. Those copays on the commercial side are in the, call it $30-$60 a script, and they could be as much as double that on the Medicare side. That's a broad generalization. You got to look at each plan and see how and each plan will actually have different benefit designs that will depend upon how much the patients are paying for it and how much the sponsored company is paying for it. It gets really complicated, but generally, that's what we would expect to see. Okay. Just to clarify, do you expect patients to use one script per episode or kind of stretch that out between two episodes? No. Right now, we go to market with a single script that has a container in it with two devices b ecause we hope our approved label would say, "Use one device. If you still have symptoms 10 minutes later, use the second device. Now you're out of devices. You need to get a new script or a refill. Okay. Some patients will only use one dose. They'll be able to stockpile the other one, but we'll still encourage them to go get a refill script, because we always want patients, for any episode that presents, to have the availability of two doses to treat that episode per the evidence from our randomized clinical program. Great. Thank you very much. Okay. Hi, Luis Santos here from H.C. Wainwright in for Patrick Trucchio as well. Again, congratulations on the progress you've been doing and everything you've handled from the first NDA to handling all of the ramp-up into what we hope is going to be a positive outcome in March. Everything that's in your hands and the execution that you're planning is on point, and we're very positive on that. My questions are focused on what might not be on your hands, which is the potential for electrophysiologists to have those two scenarios of switching. So using CARDAMYST for bridging to an ablation or even as an alternative to an ablation. You said one out of three EPs will suggest the bridging. You anticipated achieving a target population within the three years of launch. My numbers are not meeting within those three years, if it's just one-third of the EPs suggesting that use. The other one in line with that is the reductions in visits, the expected reductions in clinical visits by using CARDAMYST, which was about 40%, even if it's 50%. How does this come into the expected ramp-up in the next three years to achieve that target population? Thank you. Okay. Let me start with the EPs. I apologize if I didn't describe this carefully, but that slide didn't suggest that only a third of EPs would use CARDAMYST as a bridge to ablation. It was a statement about all EPs on average using it for a third of their patients that they're bridging to an ablation. It wasn't a subset of EPs, it was the percent of their patient population that they would think would be appropriate to bridge to an ablation. In some cases, they schedule ablation a week later. There's not much need for a script. If it's months, they would see. That's part of the variability around that 33% you saw. Yeah. Lorenz, if I could add that. Why would they need a bridge for ablation? Well, right now, about two-thirds of these patients coming into them are on background beta blockers and calcium channel blockers. To do an ablation, you actually have to induce SVT. They have to take them off of those background beta blockers and calcium channel blockers that suppress episodes. When you take a patient off that, what would you say, a week before your ablation, two weeks before ablation, to get their system settled, you have a greater chance of having episodes, right? Because they do help tamp down those episodes, so why not have CARDAMYST available? That's kind of the underlying reason for why you would want to bridge with etripamil if you want. Yeah. Just two add-on points to your question. The first one is to delineate what Lorenz already started to explain. That is, those are statistics that were collected from electrophysiologists. Still, nonetheless, electrophysiologists don't see every patient with SVT. Of the patients they see, they have their practice patterns. A good portion of the patients, the great majority of SVT patients actually, are seen and treated by the general cardiologist. The question is, what percentage of those patients go on to ablation? We published other work that would indicate that only about 15% of patients in the United States who are eligible to get an ablation actually get an ablation. We can talk about the reasons why, but the point is, once the patient makes it to the electrophysiologist, that's something only a minority of patients do. Yeah. The second thing I just wanted to elaborate on is you asked about ER visit frequency. I think what you're driving at is it's great there's a 50% reduction in ER visits. Why isn't it greater? Or what's happening to the other patients? What happens unfortunately is there's a large number of patients who just suffer in silence, which is really, really sad, but it happens. Number two is you only need one trip to the ER as an SVT patient to remind yourself that you don't want to be in the ER. The drug that Lorenz mentioned, IV adenosine, works really quickly. It works quickly by stopping your heart, and that's something that patients just. Your heart literally stops for a number of seconds. You feel like you're going to die, literally. That's something that patients don't want replicated unless they're really in extremis. A lot of patients still suffer in silence. Luis, if you give it to Athena. Hi, guys. This is Athena Chin on for Ritu Baral at TD Cowen. Thanks for taking the question and congrats on all your progress. For the 60 reps you do plan to hire, how much will that cost fully loaded? And for the different use cases you discussed, how are you thinking about the frequency of CARDAMYST use across all of them? Like, for the pill-in-the-pocket patients, do you expect that use to be more frequent than the folks who are waiting for their ablations and how are you thinking about that average three to five uses per year when applied to the three different buckets? Thank you. Wow, great questions. I don't know if we've got that one yet broken down by the subcategories. Lorenz, I'm sure you're able to talk about how much a rep costs. Yeah. We've not divulged specifically what our OpEx is going to be, but in general, there's published data sources that I actually used years ago to estimate this. A specialty rep is more expensive than a primary care rep, not as much as an oncology rep or a rare disease rep. In general, a fully loaded cost of a rep from a budgeting standpoint, which includes the cost of the rep, their car, their manager, their regional sales director, their walking around money, all that stuff. Somewhere between $250,000-$300,000. All the comm ops support as well, that's all loaded into that number. It's like a sales and sales ops support for a sales rep. That's how you can dollarize a sales force that's a specialty rep. That's not specific to us. That's in general across specialty sales forces. Yeah. Lorenz, do we have an opinion on the utilization or the amount of uses per year, depending if they came from pill-in-the-pocket or if they came from an ablation clinic? I don't think we've had that. It's interesting. I meant what I said, but literally, doctors tell us, "I would use the drug in all these different cases." It'll be very specific to the patient. There are some doctors, a minority, that sort of believe a little bit more in pill-in-pocket or want to believe or hope that pill-in-pocket actually works, and they might be different than a doctor that's just really frustrated with pill-in-pocket. I would think of pill-in-pocket, that 30% of the market where we saw two-thirds shift to CARDAMYST, to me, that's the lowest hanging fruit. If nothing else, it would be obvious for a doctor to stop writing pill-in-pocket and give them CARDAMYST because it's just so much better on every. Even though we haven't done a head-to-head trial, doctors tell us and report to us it's just better on every dimension, efficacy, safety, convenience, all of it. There's other patients that don't use pill-in-pocket that can't tolerate the chronic meds and the prophylaxis, or they continue to have lots of episodes even though they're on these daily beta blockers. If that's the case, the doctor's probably not likely to add pill-in-pocket because they already can't tolerate that med anyway when you take it chronically. Again, more likely to use CARDAMYST. It's a very diverse set, and that means commercially, when we launch, we want to be really clear with our reps when they go in and talk to the doc, convince them CARDAMYST is a good choice to give them clear guidance on the kind of patients they should really look for, where they're going to get the most bang for their buck. That's really more about not so much about narrowing the scope, but more about the physician having a clear picture in their head about who they're looking for so that the next time they come in, they immediately say, "Hey, I got a new drug for you." Or better yet, tell the nurse to go call a dozen patients in the practice and say, "Don't come in November. Come to the back of my office in July. I got something new for you because I've been telling you about this and it's actually here. That's not a broad strategy, but we do think there'll be some of that dynamic as well as we get into word of mouth and all the announcement around the approval, et cetera. Yeah. Yeah, Athena, one other comment I'll make that your question sparked, and we've had a lot of debate around our table as to whether that three to five is conservative or not. We think it is. It's partially because what we see in the clinical trials is a dynamic where some patients carry their kit in the clinical trial. It's their drug, it's their monitor, it's their instructions. They don't go anywhere without this kit. If they leave for work and they left the kit at home, they go home and get it and go to work with it. Others are a little bit more like, "Oh, if I miss this episode, the next one I'll use the kit on." What's clear to us is that when they use it, they report a good experience, and they're more inclined to want to have it available for the next time. We believe or speculate rather, that in that three to five, that that could be an underestimate because as they get comfortable with the episodes and with CARDAMYST used for that episode, and you weed out the ones that it doesn't work on, right about 20%-30% do not work even after an hour and a half. You're going to be left with a population that's more inclined to have it with them all the time. That data that Lorenz showed from a clinical trial, that's when you only have one available, right? In the real world, they're going to have one at the office. You'll probably have one at home, right? You won't have to go back and get it if you left it at home. You'll have it in your desk drawer. We think that the experience from the clinical trial is a little bit conservative because again, you only have one, and life doesn't work that way, right? Life works where I got to have it available to me whenever. I have it in the real world, they should have it, or we expect them to have it in their briefcase, in their desk drawer, and in their home. Chris. Serge Belanger from Needham. We're about a month out from your PDUFA. Anything you can share about interactions with FDA as you enter the final stretch here? And then from a label perspective, what are your expectations for that label? Anything that would be nice to have and nice to not have? Yeah, sure. We always get the how's it going with the FDA question, and we've been pretty consistent with this group at Cardiorenal. I think we're very clear and been forthright with investors, certainly through the mid-cycle meeting, that we took a lot of confidence in the fact that FDA is really engaged. They've asked questions across a range of areas. Very importantly, it is a drug device combo. We got questions from the device division by the mid-cycle meeting. These are all things that we had on our tick box list to make sure we were hopeful that we had that engagement. We don't comment specifically on any questions or areas that we're going into, but we feel really good. The other thing, we read a lot about changes to the administration or changes to the FDA as a result of changes in administration. We really haven't seen much from our interactions with this division. Again, we're pretty late in the game here when the Trump administration came in. That all looks the same as where it was in the beginning. With regard to the label, we think it's a kind of pretty vanilla, meat and potatoes label. You can almost look at verapamil and put in place that this drug is being used without medical oversight, and that's your label. It's for use in PSVT. Pretty simple. What we will not have in the label, we don't expect to have anyway, is the emergency department reductions. We knew that going into it. We'll engage the agency on that matter, but we're not expecting that. The good news is that we've published on that, and payers tell us that that's adequate for them to have those discussions on the label. Just to repeat, the most important thing for this drug in the label is to show that it's safe. That safety is crystal clear in the RAPID trial, and we're expecting that table that you saw or something similar to it to come through in this label. That would be a home run for us. It's what we expect, and it's what allows us to really promote this drug. To be clear, Serge that's the IV verapamil- Yes -label, not the oral, right? That's our target. Because the pharmacokinetics are totally different versus an oral. Yeah. Okay. We have some questions from the web audience that we should. Hold on. We got one more from Ted here, and then we'll go to the web. Sorry. Sorry, just one more quick one. How many patients are currently on the extended access that would convert over to commercial? How much commercial supply do you have, or how should we assess that? What do you think would be standard COGS for the net pricing that you've given us of sort of the $500-$1,000? Thanks. Yeah. I don't think we've ever disclosed a number on expanded access. I'll ask for your help on COGS a little bit. It's relatively small numbers, Ted. We had global programs. We really brought our expanded access programs to the U.S. only, and I would say they're relatively small relative to conversion, if you will, and impacting the market. With regards to COGS, I'd say we're kind of in that low double digits type of COGS percentage relative to CARDAMYST. Jeff, can you help me out a little bit? Yeah. I think we can safely say we'll be about 10% of the net. Yeah. Okay. Did I miss a question there? In terms of manufacturing? Yeah, for supply. Oh, okay. All of our vendors have plenty of capacity is what it boils down to support us well into probably 2027, even if we exceed our projections by quite a bit. Maybe later this year or 2026, we'll want to invest in some scale-up on a couple of choke points, but we don't anticipate supply problems. Great. Okay, Michael, you say you had one online? Yeah. Question from JTB Capital Management. The vast majority of patients diagnosed with PSVT today are controlled by taking generic beta blockers or calcium channel blockers that are relatively inexpensive. How do you foresee the progression of formulary access? Well, as I showed you, the vast majority of patients are not controlled on those meds. They do take them, whether it's a chronic prophylaxis, as the questioner asks, or even the pill-in-the-pocket. Everything we've seen today shows that that's clearly not sufficient. It doesn't reduce the frequency to zero. It doesn't even reduce it by a whole lot. Pill-in-the-pocket is really just that. It's just a hope that maybe it'll do some good for the patient. When we engage payers, we're not hearing a lot of what you might expect to hear, which is, "Well, we're going to compare you to generic drugs," or, "We're going to compare you to IV adenosine." They get the use case at home, where there are no approved treatments other than a vagal maneuver. When you're in an attack, there's nothing you can do that's on-label and approved for that patient. We've demonstrated in our clinical program that we work on top of chronic oral prophylaxis. Two-thirds roughly of our patients, or the majority of our patients were on prophylaxis still had episodes. We see the same thing in market research. We saw the same thing in our observational study. We're just adding a better treatment that will add on or replace existing things that over the years have been used but are not particularly effective. I think an important comment, and we've seen it in our trial data, is most of these patients will try orals, but a lot of them stop because they don't like the way it feels and because it does not work for them. You could see if you ask people, "Have you ever?" The percentages are very, very high. You ask them, "Are you on them now?" The percentages are, like, half of that. Generally, when people think of this management, they're like, "Everybody's on pill-in-pocket," but it's not true, because a lot of people drop out. In our trials, as Lorenz mentioned, a lot of them were on a background therapy, but still their PSVT is bad enough that they're entering a clinical trial for something else. I think that's pretty notable for what the real opinion of the efficacy of these things are. Thanks. Next question from Ned Brokaw of BCM. Again, Lorenz, I think you alluded to this on your slides, but how many physicians are targeted on the initial launch? Yeah. It was on a slide, so you can go back and look. We're targeting 10,000-12,000, mostly cardiology targets at approval. We imagine over two years ramping that up to 25,000-30,000 targets as we get broader commercial and then eventually government coverage. Yeah. Do you want to mention a little bit about the target of the site as well as the physicians and the efficiency that comes with that? Yeah. If you think about going to market, a lot of times you think about a rep calling on a doctor. That is still the fundamental calculus of figuring out how big a sales force and who you ultimately go, because it's not a group practice that writes a script, it's an individual physician. Having said that, cardiology over my career has certainly gone from mostly individual practitioners to mostly large group practices or being bought out by hospital systems. We think about our opportunity. We certainly know who the big prescribers are and where most of the patients are being treated. We think about it calling on an account, not just an individual physician, because once we've deployed the rep and spent money to send them to a particular address to call on Dr. Bharucha, Dr. Bharucha has 15 other cardiologists that work with him and a bunch of nurse practitioners and some PAs and even some office staff. This is going to be a very important, what we call a total office call or a total practice call. We'll be targeting not just individual physicians, the 10,000-12,000 I mentioned, but also very much focusing on anyone who touches or can touch that patient within that practice. Thanks. One more here from Michael Lindsay at Barrington Holdings. Are there any plans to gain approvals in other markets such as Europe, Japan, China? Yes. We had a global program that included sites in North America, South America, and Europe. We feel it's very representative of the condition. We are in the process of filing in the EU at the moment, and are engaged in those discussions with our rapporteurs already. It's just lagged behind the U.S. simply because we're a small company and want to really focus our efforts on the U.S. for the approval. Really what opened up our ability and interest to file in Europe a little earlier than we originally planned was when the FDA told us we were likely not to have an AdCom. We allowed those resources that were input towards an AdCom to really be put on the European filing. Thanks. I think that's all we have from the web audience right now. Okay, great. With that, I'll just thank certainly everyone in the room for coming out and also those online for listening to the Milestone story. We'll be around. We'll also be at a conference next week. At some point, as we get a little closer to the approval, we're going to go into a dark period. Really appreciate everyone coming with their questions today. Thanks so much. Thank you.